PMA P160030S058

Device: Freestyle Libre Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P160030
Supplement: S058
Product code: PZE
Decision date: 2026-09-01
Classification: Clinical Chemistry
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Approval order statement: addition of a secondary supplier and manufacturer for subcomponents and subassemblies for sensor kits. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Flash Glucose Monitoring Systems

Current openFDA PMA Record#

Device: Freestyle Libre Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P160030
Supplement: S058
Product code: PZE
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Decision date: 2026-09-01
Decision code: OK30
Date received: 2026-08-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a secondary supplier and manufacturer for subcomponents and subassemblies for sensor kits. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Flash Glucose Monitoring Systems